(136 days)
The ProToe™ EndoSorb™ Small Hammer Toe Pin is indicated for proximal interphalangeal (PIP) joint arthrodesis.
The ProToe™ EndoSorb™ Small Hammer Toe Pin is made out of the bioresorbable EndoSorb™ material and is indicated for proximal interphalangeal (PIP) joint arthrodesis. EndoSorb™ is a polyerster derivative of L-Lactic and glycolic acids. Poly(L-lactide-co-glycolide) material (PLGA) degrades and resorbs in vivo by hydrolysis into L-lactic and glycolic acids, which are then metabolized by the body. The device has threads on one side and barbs on the other.
The provided text describes a 510(k) premarket notification for a medical device called the ProToe™ EndoSorb™ Small Hammer Toe Pin. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a performance study. As such, the information you're asking for, such as acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment, is generally not part of a 510(k) summary for this type of device.
This device is a physical implant (an arthrodesis pin) made from a bioresorbable material. Its equivalence is based on its material, design, and intended use being similar to existing, legally marketed devices. Performance for such devices is typically evaluated through bench testing (e.g., mechanical strength, degradation properties) and possibly animal studies, but the detailed methodology and results demonstrating "acceptance criteria" through a specific "study" in the way you've outlined for AI or diagnostic devices are not typically presented in this format for this type of implantable device.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text. The document focuses on establishing substantial equivalence rather than reporting on a clinical or performance study with defined acceptance criteria and statistical outcomes for a novel device.
Here's what can be extracted, demonstrating the absence of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable (N/A) | Not applicable (N/A) |
| (No specific performance criteria or results are reported in this 510(k) summary for the ProToe™ EndoSorb™ Small Hammer Toe Pin. The submission focuses on substantial equivalence to predicate devices based on similar indications for use, materials, and technological characteristics.) |
2. Sample size used for the test set and the data provenance:
- N/A. No clinical or performance study with a "test set" is described for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. No clinical or performance study requiring expert ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No clinical or performance study requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This device is an arthrodesis pin, not an AI or diagnostic tool. Therefore, an MRMC study is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device is an arthrodesis pin, not an algorithm. Standalone performance as described is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. No type of "ground truth" as relevant to diagnostic performance is mentioned. The equivalence is based on physical characteristics and intended use.
8. The sample size for the training set:
- N/A. No training set is applicable for this physical implant device.
9. How the ground truth for the training set was established:
- N/A. No training set or ground truth establishment relevant to an AI or diagnostic context is applicable.
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Submission Date: 09.02.2010
| 2 510(k) Summary | |
|---|---|
| Submitted by: | Merete Medical GmbHAlt Lankwitz 10212247 Berlin, Germany |
| FDA Registration Number: | 3002949614 |
| Contact Person: | Emmanuel AnapliotisMerete Medical, Inc.49 Purchase StreetRye, New York 10580Phone: 914 967 1532 |
| Proprietary Name: | ProToe™ EndoSorb™ Small Hammer Toe Pin |
| Common Name: | Arthrodesis Pin |
| Device Classification: | Screw, Fixation, Bone, Non-spinal, non-metallic(888.3040) |
| Product Code: | HWC |
Proposed Regulatory Class: Class II
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Small Hammer Toe Pin, Biomet, Inc. (K021828); Resorbable Hammertoe Pin, Biomet. Inc. (K011137)
Intended Use:
The ProToe™ EndoSorb™ Small Hammer Toe Pin is indicated for proximal interphalangeal (PIP) joint arthrodesis.
Device Description:
The ProToe™ EndoSorb™ Small Hammer Toe Pin is made out of the bioresorbable EndoSorb™ material and is indicated for proximal interphalangeal (PIP) joint arthrodesis. EndoSorb™ is a polyerster derivative of L-Lactic and glycolic acids. Poly(L-lactide-co-glycolide) material (PLGA) degrades and resorbs in vivo by hydrolysis into L-lactic and glycolic acids, which are then metabolized by the body. The device has threads on one side and barbs on the other.
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510(k) Submission - ProToe™ EndoSorb™ Small Hammer Toe Pin
Substantial Equivalence:
The ProToe™ EndoSorb™ Small Hammer Toe Pin is similar to legally marketed predicate device listed above in that it shares similar indications for use, is manufactured from similar materials and incorporate similar technological characteristics. Any differences have been found to have no obvious effect on the performance, function, or intended use of the prosthesis.
Software Documentation:
No software is needed for the use of this device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Merete Medical GmbH % Merete Medical, Inc. Mr. Emmanuel Anapliotis 49 Purchase Street Rye, New York 10580
JUL.-2 2010
Re: K100414
Trade/Device Name: ProToe™ EndoSorb™ Small Hammer Toe Pin Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JDW, HWC Dated: June 25, 2010 Received: June 28, 2010
Dear Mr. Anapliotis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Emmanuel Anapliotis
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Barbara Buehrig
Mark N. Me son Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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p. '1/1
Submission Date: 09.02.2010
Indications for Use Statement 1
Indications for Use
510(k) Number (if known):
Device Name: ProToe™ EndoSorb™ Small Hammer Toe Pin
Indications for Use:
The ProToe™ EndoSorb™ Small Hammer Toe Pln is indicated for proximal interphalangeal (PIP) joint arthrodesis.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Merete Medical GmbH · Alt Lankwitz 102 · 12247 Berlin, Germany · Phone: +49 (0)30 / 77 99 80-0 US Agent: Merete Medical, Inc. • 49 Purchase Street • Rye, N.Y. 10580 • Phone: 914 • 067-1552
3
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.